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HHS Draft Policy Paves Way for Unapproved Peptide Injections
29 Oct
Summary
- HHS released a draft policy allowing compounding pharmacies to sell six unapproved peptides.
- The plan largely bypasses FDA review, with FDA scientists reportedly opposing it.
- The policy aims to address risks of black-market peptides while regulating existing uses.
The U.S. Department of Health and Human Services (HHS) has released a draft policy that could allow compounding pharmacies to sell six peptide injections that have not received FDA approval. This initiative, championed by Health Secretary Robert F. Kennedy Jr., aims to regulate wellness peptides currently popular but lacking official safety and effectiveness reviews.
Sources indicate that FDA scientists had minimal input in the draft policy and largely oppose it. The proposed plan directs the FDA not to take action against compounding pharmacies that prepare these peptides. This approach seeks to counter the dangers of unregulated black-market peptides, which many Americans currently obtain from overseas online sellers.
While the policy includes safety provisions such as requiring FDA-registered factories for ingredients and tracking side effects, critics like former FDA official Dr. Peter Lurie point out the FDA's lack of enforcement power. He also noted that effective, approved medications already exist for the conditions these peptides are promoted to treat, such as insomnia and anxiety. The market for wellness peptides is valued at over $2 billion, with companies like Hims & Hers planning to offer them once regulations change.
In 2023, the FDA had previously listed some of these peptides, including BPC-157 and TB-500, as substances pharmacies should not compound due to concerns about tumor growth and kidney damage. However, an HHS-selected panel voted to remove restrictions on these and four other peptides. The public has a two-week period to comment before the policy is finalized.
